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A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

NCT06346067 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2026-02-27

No results posted yet for this study

Summary

Stage 1: To select the optimal dose of naporafenib + trametinib to be studied in Stage 2.

Stage 2: To compare progression free survival (PFS) and overall survival (OS) for patients with NRAS-mutant (NRASm) melanoma who are randomized to receive the combination of naporafenib + trametinib to that of patients who are randomized to physician's choice of therapy (dacarbazine, temozolomide, or trametinib monotherapy).

Conditions

  • Advanced or Metastatic NRAS-mutant Melanoma

Interventions

DRUG

Naporafenib

Naporafenib (ERAS-254) is an experimental Pan-Raf inhibitor

DRUG

Dacarbazine

Dacarbazine IV - Day 1

DRUG

Temozolomide

Temozolomide 200 mg/m2/day PO on Day 1 to Day 5 of each 28-day cycle

DRUG

Trametinib

Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.

Sponsors & Collaborators

  • Erasca, Inc.

    lead INDUSTRY

Principal Investigators

  • Joyce Antal · Clinical Development

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-29
Primary Completion
2028-04-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06346067 on ClinicalTrials.gov